Appendix C – Informed Consent Release

advertisement

APPENDIX C

INFORMED CONSENT RELEASE

Investigator:

“ My name is (name of investigator) , and I am a/an (undergraduate/graduate student, faculty member, etc.) at (name of institution/facility) . I am inviting you to participate in a research study. Involvement in the study is voluntary, so you may choose to participate or not. I am now going to explain the study to you. Please feel free to ask any questions that you may have about the research; I will be happy to explain anything in greater detail.

“ I am interested in learning more about (state what the research is about) . You will be asked to (state what the participant will be asked to do.) This will take approximately ( ) min./hrs. of your time. All information will be kept (either confidential, in the case where subjects' identities need to be retained or can be associated with their responses, or anonymous and confidential, in the case where data collection does not allow responses to be connected with a particular subject) . If anonymous, this means that your name will not appear anywhere and no one except me will know about your specific answers. If confidential, I will assign a number to your responses, and only I will have the key to indicate which number belongs to which participant. In any articles I write or any presentations that I make, I will use a made-up name for you, and I will not reveal details or I will change details about where you work, where you live, any personal information about you, and so forth.

“The benefit of this research is that you will be helping us to understand (topic of research).

This information should help us to (benefit of the research, better understanding, etc.). The risks to you for participating in this study are (state the risks to subjects).

These risks will be minimized by (state the procedures you will use to minimize the risks).

If you do not wish to continue, you have the right to withdraw from the study, without penalty, at any time.”

Participant -

“All of my questions and concerns about this study have been addressed. I choose, voluntarily, to participate in this research project. I certify that I am at least 18 years of age [or have a signed parental consent form on file with the______________________________ department].

print name of participant signature of participant print name of investigator

date

(informed consent) p. 1 of 4

signature of investigator date

(informed consent) p. 2 of 4

TO THE RESEARCHER:

ISSUES TO BE AWARE OF WHEN OBTAINING INFORMED CONSENT

Abuse

If a researcher is asking about care-taking practices or observing in a child's home, the researcher would need to indicate what his/her reporting responsibility is in the event of child abuse.

Another example might be if the researcher determined that subjects were at risk for harming themselves or others. If the researcher felt bound to notify someone about that risk, subjects should be notified of that obligation when asking for their participation.

Anonymous and Confidential Data Collection

Indicate whether data collection will be (a) anonymous or (b) confidential. The term

"anonymous" is used when the investigator collects no identifying information about subjects and, thus, an individual data sheet cannot be connected with a specific subject (by the investigator or anyone else) once the data are collected. As an example, tape-recording, by its very nature, cannot be considered anonymous.

Confidentiality, in contrast, refers to collected data that can be linked to an individual subject.

For example, assigning subjects numbers, but then keeping a "key" that links the numbers to identifying information, is a procedure one might use in order to preserve confidentiality. Not identifying subjects by name or by any other identifying information in reports and presentations also is a measure taken to preserve confidentiality. If individual subject data are used as illustrative examples, you must assure subjects that this will be done in a way that does not allow identification of the participant. Care must be taken to not only not divulge subjects' names, but also other details about them or their experiences that would allow them to be identified.

Occasionally, it is important to the research to identify an individual who participated, or subjects themselves may wish to have their contribution attributed to them. In such cases, it would be necessary for a participant to sign a release form indicating their willingness to be so identified.

Audio- and Videotaping

If you wish to tape subjects, please include a request to tape explaining the type (e.g. videotaping in the classroom, audiotaping, single or group interviews, etc.), and the disposition of the tape(s) when the study is complete. If the tapes will be used for any other purpose, clearly state the who, where, and why of the other use; if there is no other use of the tape, simply stating that it will be erased when the study is complete is sufficient.

Benefit to the Participant

If it is too strong a statement to say that the subject will benefit from the research, perhaps the better statement would be that the subject may benefit from the research.

Contact Information

Include contact information - a phone number, and/or e-mail address where subjects may reach you. If a student is conducting the study, the advisor's name and phone number should also be provided.

Identifying References

In the event that potentially identifying references need to be included in publications or presentations in order to maintain the basic integrity of the study, the researcher needs to specifically include that fact in the written informed consent statement.

(informed consent) p. 3 of 4

Illegal Activities

Researchers must indicate the limits of the confidentiality. If the researcher plans to ask subjects about their or others' illegal activities (underage drinking, drug use, etc.), the consent form must indicate that the researcher's data can be subpoenaed. The consent forms should include the following sentence: "The researcher is not immune to legal subpoena about illegal activities.

Although it is very unlikely, if law enforcement officials asked to see my data, I would have to comply with that request."

Problematic Language

Language used in the informed consent form should be simple and direct.

Consider the following examples: (1) Problematic language: “The purpose of this study is to validate the concept of citizenship and to determine the public’s view on the rights and responsibilities citizenship entails.” (2) Preferred language: “This study is designed to find out about what being a citizen means to you.”

Use of Minors

The special vulnerability of children makes consideration of involving them as research subjects particularly important. To safeguard their interests and to protect them from harm, special ethical and regulatory considerations are in place for reviewing research involving children. Considerations must be taken of the benefits, risks, and discomforts inherent in the proposed research and to assess the justification in light of the expected benefits to the child-subject or to society as a whole.

Withdrawal from Study

You must state that participation is voluntary and that subjects "may withdraw at any time up until the study has ended." You also must indicate that subjects will not suffer in any way from withdrawing. Wording of this may depend upon the specifics of the study. Examples: (1) If subjects are receiving a service from the agency where the research is occurring, they should be told that they will still continue to receive services even if they decide not to continue participating in the study. (2) If subjects are students in a class or employees in a company, they should be told that their decision to stop participating will not negatively affect a grade or performance evaluation, or participants will be informed on the consent form and by the test administrator that "participation in the study is voluntary and that they can withdraw from participation at any time without penalty."

(informed consent) p. 4 of 4

Download